Manufacturer
Ids, LimitedPICOSECOND Nd:YAG Laser System
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K233018
- Device name
- PICOSECOND Nd:YAG Laser System
- Company
- Ids, Limited
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-09-22
- Decision date
- 2023-12-21
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Intended Use
The PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). The 532nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Device Description
The PICOSECOND Nd:YAG Laser System (PICO PREMIUM) is a laser surgical instrument intended for use in general and plastic surgery and in dermatology. It operates at two wavelengths: 1064nm for dark colored tattoo inks and multicolored tattoos, and 532nm for lighter colored tattoo inks.
Summary parsed at:2026-06-01 05:33:28 UTC
Predicate devices
1Picocaremajesty
K233018 references 1 predicate/reference device
Cited as predicate
2Picosecond Nd:YAG Laser Systems (BL-C10)
Multi-function Platform Systems (BL-M10)
2 submissions cite K233018 as a predicate